Caire recalls portable oxygen concentrators model AS200-3 with serial numbers CBB5221200337 and CBB5221200287 due to not being cleared for U.S. distribution. No remedy provided in official notice.
The device was not cleared for U.S. distribution.
Caire is recalling a specific model of portable oxygen concentrator that was not approved for sale in the U.S. This means the device may not be safe for use and should not be used by anyone.
The device was not cleared by the U.S. Food and Drug Administration for distribution in the United States. This means it may not meet safety standards and could pose risks if used without proper approval.
People who own or use the Caire FreeStyle Comfort Portable Oxygen Concentrator model AS200-3 with the listed serial numbers are affected. Those relying on this device for medical oxygen are at the highest risk.
Check for the model number AS200-3 on the device. The affected units have serial numbers CBB5221200337 and CBB5221200287.
Look for the model number AS200-3 on the device.
The device was not cleared for U.S. distribution by the FDA, meaning it may not meet safety standards.
The official recall notice does not provide a remedy, so contact Caire directly for guidance.
No, the device was not cleared for U.S. distribution, so it is not safe for use in the United States.
We’ve drafted a message you can send Caire to request your refund or repair — edit it as you like.
Subject: Recall Z-1117-2022 — Caire Caire Hello, I own a Caire that is covered by recall Z-1117-2022 from Caire. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
